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Telemonitoring Enhanced Support for Depression Self Management

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CarePartners for depression
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

NOTE: In order to participate, must have received medical care for past year at one of the participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester

Additional Inclusion Criteria:

  • at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months
  • depression diagnosis in medical chart problem list or billing record (ICD9 codes: 296.20-.26, .30-.36, 296.4-.9, 298.0, 300.4, 309.0-.1, 309.28, 311.00) during the past 2 years
  • current PHQ >10 (non-mild depressive symptoms)
  • at least 21 years old
  • comfortable speaking English
  • can use a touch-tone phone
  • can identify at least 1 eligible CarePartner
  • not in palliative care, on transplant waitlist, or <1 year life expectancy
  • free of major cognitive impairment or psychiatrically unstable
  • not experiencing domestic abuse or stalking

Exclusion Criteria:

  • Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care
  • At risk for domestic abuse, PHQ<10, end stage renal disease, lung cancer, dementia, bipolar disease, schizophrenia, limited life expectancy (advanced stage cancer/heart failure/on oxygen), alcohol problems, receiving palliative care
  • Unable to speak English
  • Not planning to get all or most of care at study site
  • Primary care physician not affiliated with study site
  • Unable to use telephone to respond to weekly automated self-management support calls
  • Unable to nominate an eligible CP

Sites / Locations

  • Alcona Health Centers
  • University of Michigan
  • Dua Family Practice
  • Morang Chester
  • Hamilton Community Health Network, Inc.
  • Cherry Street Health Services
  • Muskegon Family Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CarePartners for depression

Usual care

Arm Description

For one year, patients receive weekly automated telemonitoring of mood and self-management, while their CarePartners receive weekly reports of the patient's assessment results with tailored instructions on supporting the patient's depression self-management.

Usual medical care.

Outcomes

Primary Outcome Measures

Depressive symptom severity
Patient Health Questionnaire 9 (PHQ-9).

Secondary Outcome Measures

Depression remission rate
Remission as measured by PHQ-9 <10
Depression-related functional impairment
Sheehan Disability Scale
Positive well-being
Positive well-being will be assessed using the REMIT, a 5-item scale of positive affect and other aspects of depression recovery developed by the PI and his colleagues. Reference: Nease DE, Jr., Aikens, JE, Klinkman, MK, Kroenke, K, and Sen, A. Toward a more comprehensive assessment of depression remission: the Remission Evaluation and Mood Inventory Tool (REMIT). Journal of General Hospital Psychiatry. 2011.
Health care costs
Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases.

Full Information

First Posted
September 13, 2012
Last Updated
March 6, 2019
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01834534
Brief Title
Telemonitoring Enhanced Support for Depression Self Management
Official Title
Telemonitoring Enhanced Support for Depression Self Management
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this research is to test the efficacy of "CarePartners for Depression" (CP-D) intervention, which was designed to increase between visit monitoring of depression status and enhance self-management. **In order to participate, subjects must be patients at participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester.
Detailed Description
This project will test a practical intervention that uses low cost technologies to activate depressed patients' existing social networks for self-management support. The intervention links patients with a "CarePartner" (CP), i.e., a non-household family member or close friend who is willing to support the patient in coordination with the clinician and any existing in-home caregiver (ICG). Through weekly automated telemonitoring, patients report their mood and self-management status, and receive tailored guidance on self-management. The CP receives a corresponding update along with guidance on how to best support the patient's self-management efforts, and the primary care team is notified about clinically urgent situations. The intervention will be tested among depressed primary care patients from clinics serving low-income and underinsured patients, whom the intervention was especially designed to benefit. Specific Aim 1 is to conduct a randomized controlled trial to compare the effectiveness of one year of telemonitoring-supported CP for depression versus usual care (control) on depression severity. Specific Aim 2 is to examine key secondary outcomes (response and remission, impairment, well-being, caregiving burden, healthcare costs) and potential moderators. Specific Aim 3 is to use a mixed-methods approach to enrich our interpretation of the statistical associations, and to discover strategies to enhance the intervention's acceptability, effectiveness, and sustainability. If the intervention proves effective without increasing clinician burden or marginal costs, then its subsequent implementation could yield major public health benefits, especially in medically underserved populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CarePartners for depression
Arm Type
Experimental
Arm Description
For one year, patients receive weekly automated telemonitoring of mood and self-management, while their CarePartners receive weekly reports of the patient's assessment results with tailored instructions on supporting the patient's depression self-management.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual medical care.
Intervention Type
Behavioral
Intervention Name(s)
CarePartners for depression
Intervention Description
Automated telephone calls for depression monitoring and self-management support.
Primary Outcome Measure Information:
Title
Depressive symptom severity
Description
Patient Health Questionnaire 9 (PHQ-9).
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Depression remission rate
Description
Remission as measured by PHQ-9 <10
Time Frame
12 months after randomization
Title
Depression-related functional impairment
Description
Sheehan Disability Scale
Time Frame
12 months after randomization
Title
Positive well-being
Description
Positive well-being will be assessed using the REMIT, a 5-item scale of positive affect and other aspects of depression recovery developed by the PI and his colleagues. Reference: Nease DE, Jr., Aikens, JE, Klinkman, MK, Kroenke, K, and Sen, A. Toward a more comprehensive assessment of depression remission: the Remission Evaluation and Mood Inventory Tool (REMIT). Journal of General Hospital Psychiatry. 2011.
Time Frame
12 months after randomization
Title
Health care costs
Description
Health care costs will be estimated using data gathered from a variety of patient self-report and site-specific administrative databases.
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
NOTE: In order to participate, must have received medical care for past year at one of the participating clinics: Alcona Health Center, Cherry Street Health Services, Dua Family Practice, Morang Chester Additional Inclusion Criteria: at least 2 outpatient primary care visits in the past 2 years, 1 within the past 13 months depression diagnosis in medical chart problem list or billing record (ICD9 codes: 296.20-.26, .30-.36, 296.4-.9, 298.0, 300.4, 309.0-.1, 309.28, 311.00) during the past 2 years current PHQ >10 (non-mild depressive symptoms) at least 21 years old comfortable speaking English can use a touch-tone phone can identify at least 1 eligible CarePartner not in palliative care, on transplant waitlist, or <1 year life expectancy free of major cognitive impairment or psychiatrically unstable not experiencing domestic abuse or stalking Exclusion Criteria: Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage renal disease), receiving palliative care At risk for domestic abuse, PHQ<10, end stage renal disease, lung cancer, dementia, bipolar disease, schizophrenia, limited life expectancy (advanced stage cancer/heart failure/on oxygen), alcohol problems, receiving palliative care Unable to speak English Not planning to get all or most of care at study site Primary care physician not affiliated with study site Unable to use telephone to respond to weekly automated self-management support calls Unable to nominate an eligible CP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James E Aikens, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John D Piette, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alcona Health Centers
City
Alpena
State/Province
Michigan
ZIP/Postal Code
49707
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48013
Country
United States
Facility Name
Dua Family Practice
City
Canton
State/Province
Michigan
ZIP/Postal Code
48187
Country
United States
Facility Name
Morang Chester
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48224
Country
United States
Facility Name
Hamilton Community Health Network, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48505
Country
United States
Facility Name
Cherry Street Health Services
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Muskegon Family Care
City
Muskegon Heights
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34086485
Citation
Aikens JE, Valenstein M, Plegue MA, Sen A, Marinec N, Achtyes E, Piette JD. Technology-Facilitated Depression Self-Management Linked with Lay Supporters and Primary Care Clinics: Randomized Controlled Trial in a Low-Income Sample. Telemed J E Health. 2022 Mar;28(3):399-406. doi: 10.1089/tmj.2021.0042. Epub 2021 Jun 4.
Results Reference
derived

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Telemonitoring Enhanced Support for Depression Self Management

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